Medial Unicondylar Knee Arthroplasty vs Total Knee Arthroplasty
NCT03396640 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350
Last updated 2023-10-23
Summary
In treatment of isolated medial unicondylar osteoarthritis of the knee (MU-OA), it is possible to choose between surgery with a unicondylar knee arthroplasty (UKA), or a total knee arthroplasty (TKA).
Supporters of TKA suggest that this treatment gives a more predictable and better result, whereas supporters of UKA suggest that it is unnecessary to remove decent and functional cartilage in other compartments, and also that generally the UKA gives better results under certain circumstances. If the UKA is worn out or loosens, revision surgery will be relatively easy, whereas revision-surgery after a TKA can be much more problematic.
Also, it is of great interest to measure the direct costs of these treatments. Both general hospital costs, but also costs in societal in terms of sick-days, pain-killer expenditure, and physiotherapy.
The aim of this study is to compare the results, in terms of 1) patient-reported outcomes, 2) clinical results including prosthetic survival and 3) costs.
Conditions
- Osteoarthritis, Knee
Interventions
- PROCEDURE
-
Unicondylar Knee Arthroplasty
Incision will be midline incision, as with a TKA, for maximum security of blinding. Standard operative technique will hereafter be used, with minor individual preferences for each surgeon as to whether tourniquet/not, drain or not.
- PROCEDURE
-
Total Knee Arthroplasty
Incision will be midline incision, as standard. Standard operative technique will hereafter be used, with minor individual preferences for each surgeon as to whether tourniquet/not, drain or not.
Sponsors & Collaborators
-
Naestved Hospital
collaborator OTHER -
Vejle Hospital
collaborator OTHER -
Aarhus University Hospital
collaborator OTHER -
Aalborg University Hospital
collaborator OTHER -
Svendborg Hospital
collaborator OTHER -
Bispebjerg Hospital
collaborator OTHER -
Randers Regional Hospital
collaborator OTHER -
Regionshospitalet Silkeborg
collaborator OTHER -
University Hospital, Gentofte, Copenhagen
lead OTHER
Principal Investigators
-
Anders Odgaard, Consultant · Gentofte Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 110 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-08-17
- Primary Completion
- 2041-10-16
- Completion
- 2041-10-16
Countries
- Denmark
Study Locations
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